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News & Analysis | REG•WATCH Blog | Press Room
Tuesday, October 14, 2008
Advice on Plastics Chemical Marred by Scandal Again
Over the weekend, the Milwaukee Journal-Sentinel broke the news that the head of an FDA advisory panel studying the safety of the chemical bisphenol-A (BPA) has ties to an "anti-regulation activist" who happens to think BPA is perfectly safe.
The activist and retiree from the manufacturing industry, Charles Gelman, was "once labeled the second worst polluter in Michigan by the state's Department of Natural Resources," according to the Journal-Sentinel. Gelman donated $5 million to the University of Michigan Risk Science Center which is headed by Martin Philbert. Philbert is also the chair of the FDA Science Board's subcommittee on BPA.
That committee is preparing to release its opinion on the safety of BPA, a chemical used in hard plastics and in the lining of food cans. The committee's recommendation could affect FDA's decision to limit BPA in consumer products or its decision not to regulate at all.
Currently, FDA says BPA is safe at levels to which humans are exposed. But that opinion has been marred by its own controversy. FDA is relying on two flawed studies, according to the House Energy and Commerce Committee: [I]t appears that the Food and Drug Administration's position on BPA's safety is entirely dependent on two studies, both of which are funded by the American Plastics Council, and one of which has not been published or peer-reviewed."
The lion's share of scientific literature would move FDA toward a finding that BPA is not safe, according to The Washington Post: "From 1997 to 2005, 116 studies of the compound were published. Of those funded by government, 90 percent showed evidence of a health effect linked to BPA."
But even after JAMA published a new study finding evidence of harm in humans exposed to BPA (which was first presented in front of Philbert's committee), FDA officials continue to tell the public BPA is perfectly safe.
Philbert says Gelman has not, and will not, affect his decisionmaking. Gelman says he has told Philbert on multiple occasions that he believes BPA is safe. Philbert denies he and Gelman spoke on the matter.
He-said-he-saids are tough to settle, but the circumstantial evidence doesn't look good: Gelman made the contribution either shortly before or shortly after Philbert was named committee chair, according to the Journal-Sentinel.
Public health advocates had hoped the advisory panel's recommendation would provide clear cut advice that FDA would be pressured to follow. Three recent studies have raised additional flags about BPA's safety. Unfortunately, regardless of whether Philbert's judgment is colored, the panel's credibility is suffering.
FDA should have done a better job of weeding out this potential conflict. Philbert did not declare the donation when filing the requisite conflict-of-interest disclosure information, but FDA's response to the new scandal is just as pitiful as its vetting of him. From the Journal-Sentinel:
Norris Alderson, the FDA's associate commissioner of science, learned of the link from the Journal Sentinel. He looked into the matter and said he was satisfied there was no conflict of interest because Philbert's salary is not paid by the donation.
Considering Philbert is a founder and co-director of the now-flush-with-cash Risk Science Center, Alderson's claim is ridiculous.
Posted by Matt Madia
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